{"id":12897,"date":"2026-09-24T14:07:22","date_gmt":"2026-09-24T12:07:22","guid":{"rendered":"https:\/\/www.scame.it\/pharma-medical\/"},"modified":"2026-10-05T10:57:25","modified_gmt":"2026-10-05T08:57:25","slug":"pharma-medical","status":"publish","type":"page","link":"https:\/\/www.scame.it\/en\/pharma-medical\/","title":{"rendered":"Pharma & Medical"},"content":{"rendered":"\r\n\r\n
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A developing area<\/div>\r\n \r\n

Pharma & Medical<\/h3> <\/div>\r\n\r\n

For over ten years Scame Mastaf has produced components in which a non-conformity is not a cosmetic defect but a functional risk. In 2026 we completed the certification portfolio that brings that capability into the pharmaceutical and medical sector: ISO 13485 in March, UNI EN ISO 15378 shortly afterwards. <\/p>\n

This page sets out what we are able to do today, under which certifications and with what documentary evidence. It contains no promises about capabilities we do not yet have. <\/p>\n

We review your design for manufacturability at no cost: we look at geometry, material and process and tell you what can be improved before the design is closed. If complex engineering changes or a CAD redesign are needed, we quote that work separately. <\/p>\n<\/div>\r\n \r\n

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The certifications covering this area<\/h3> <\/div>\r\n\r\n

Every certificate is available as a PDF, signed by the certification body, stating the sites covered and the date of the next surveillance audit. This is the level of transparency that spares a Quality Manager the preliminary documentation request stage. <\/p>\n<\/div>\r\n \r\n \r\n

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Standard<\/th>\r\n Scope<\/th>\r\n Body<\/th>\r\n Issued<\/th>\r\n Sites<\/th>\r\n Document<\/th>\r\n <\/tr>\r\n <\/thead>\r\n \r\n
\r\n ISO 13485:2021 <\/td>\r\n \r\n Medical device quality management system <\/td>\r\n \r\n ICIM <\/td>\r\n \r\n 31\/03\/2026 <\/td>\r\n \r\n Suisio <\/td>\r\n \r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 15378:2018 <\/td>\r\n \r\n Primary pharmaceutical packaging \u2014 GMP for moulders <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 22\/09\/2026 <\/td>\r\n \r\n Suisio <\/td>\r\n \r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 9001:2015 <\/td>\r\n \r\n General quality management system <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 01\/12\/1997 <\/td>\r\n \r\n Suisio
Bovezzo
Vertova <\/td>\r\n 		\r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 14001:2015 <\/td>\r\n \r\n Environmental management system <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 19\/05\/2025 <\/td>\r\n \r\n Suisio
Vertova <\/td>\r\n 		\r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n
\r\n ISO 45001:2018 <\/td>\r\n \r\n Occupational health and safety <\/td>\r\n \r\n IIP <\/td>\r\n \r\n 21\/02\/2020
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Bovezzo
Vertova <\/td>\r\n 		\r\n Download PDF<\/a> <\/td>\r\n <\/tr>\r\n <\/tbody>\r\n <\/table>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n
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What we can do<\/h3> <\/div>\r\n\r\n \r\n \r\n
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Overmoulding of metal and plastic meshes<\/h4> <\/div>\r\n \r\n
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Meshes are placed and positioned in the mould cavity before injection, with automatic in-line seal testing and dimensional repeatability across large batches. This capability was developed over ten years in household appliances and has been transferred to medical filters, HVAC, water management and instrumentation. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n

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Multi-material moulding (6K): up to six materials or colours in a single cycle qx<\/h4> <\/div>\r\n \r\n
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Sequential or simultaneous injection of up to six polymers or colours in a single production cycle. The component leaves the machine assembly-ready and replaces three or four separate parts: fewer joints, less assembly, fewer potential points of contamination. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n

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Automation with 100% inspection and Device History Record<\/h4> <\/div>\r\n \r\n
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Pre-assembly cells designed and built in-house at the moulding machine: insertion force monitoring on every part, 100% machine vision inspection, and ultrasonic welding on twelve dual-head units with energy control. On medical projects the cell generates the complete Device History Record, part by part. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n

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Industry 4.0 toolroom within the Group<\/h4> <\/div>\r\n \r\n
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Standard moulds designed and built in-house in four to six weeks, with an integrated MES and 3D presetting cycle, offline tool loading, unattended night-shift production and batch-by-batch traceability. Process documentation is available within 48 hours for an ISO 13485 audit. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n

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Food-grade GMP culture<\/h4> <\/div>\r\n \r\n
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Decades of production for the major food and beverage brands have built hygiene procedures, batch traceability and material control that are the natural prerequisite for primary pharmaceutical packaging. UNI EN ISO 15378 formalises a practice already in place. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n

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Biocompatible polymers<\/h4> <\/div>\r\n \r\n
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We assess feasibility with biocompatible polymers case by case, together with the customer, according to the device class and the validation protocol required.<\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n

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Decoration and marking on the finished component<\/h4> <\/div>\r\n \r\n
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Painting, printing and marking are carried out in-house, under the same process controls that apply to the rest of our production. The available operations are described on the Technologies page. Feasibility on devices and on primary packaging is assessed case by case with the customer, in the light of migration, cleanability and validation requirements. <\/p>\n <\/div>\r\n \r\n <\/div>\r\n\r\n \r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n <\/div>\r\n<\/div>\r\n\r\n\r\n\r\n

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We are the right supplier if<\/h3>\r\n \r\n